Submission by L. O’Donovan, N. J. Williams and S. Wilkinson
Amendments to the organ donation legislation
Question 1: Do you believe the changes we are planning to make to the Human Transplantation (Excluded Relevant Material) (Wales) Regulations 2015 are clear, achieve parity across the UK-wide system of organ donation and ensure we keep up to date with advancements in medical science?
Yes
If no, please state why
The changes are clear and achieve parity (as far as possible) across the UK-wide transplant system. However, it is disappointing that no further accompanying information about the particular transplants listed for exclusion is provided. Ensuring that policy keeps up to date with advancements in medical science should also entail providing the public with information about transplant possibilities (even if many of the organ and tissue exclusions proposed are not yet possible).
While cross-UK parity has been broadly achieved, this should not be the sole aim of Welsh policy on excluded relevant materials. Instead, a decision to exclude any particular tissue from deemed consent should be based on whether doing so serves the original aims of the shift to ‘opt-out’, namely:
(a) closing the ‘transplant gap’; and,
(b) better reflecting individuals’ wishes concerning organ donation.
Achieving parity in regulation across the UK has the potential to reduce confusion and to reduce opt- outs, thus going some way to achieving (a). In order to achieve (b) however, policymakers also need to gather reliable information about people’s views on the donation of specific tissues.
Finally, while a less substantive concern than those explained above, it should also be noted that Question 1 is itself is problematic. A consultation is an appropriate method for determining the public’s views on clarity and for eliciting responses from experts who will be able to comment on the extent to which new policy keeps up to date with scientific advancements. It is not, however, a suitable method of gaining information on the extent to which a newly proposed policy achieves parity with policy across the UK. This is a legal question, the answer to which will not change based on public opinion. It also requires respondents to have intimate knowledge of English and Scottish policy which is not provided in the accompanying documents. Indeed, both English and Scottish policies on this issue are currently in draft form which means that changes can and may still be made.
Question 2: Do you agree with the proposed new additions to the 2015 regulations (i.e. trachea to regulation 2(2); further sexual and reproductive tissues to regulation 2(3) and a new paragraph in regulation 2 about cells used in Advanced Therapy Medicinal Products?
No
If no, please state why
Given the centrality of an exhaustive list of exclusions, it is important that membership of the list is based on consistently applied and clearly articulated principles.
The inclusion of additional female and male sexual and reproductive tissues, arguably tissues of a more sensitive nature, follows the approach recently adopted by DHSC in England. The stated rationale for this explained in DHSC’s consultation response is to ‘make the list commensurate with the list of parts of the male reproductive system’ and to ‘give assurance and put beyond doubt that no part of reproductive organs and tissues will be covered by deemed consent’ (the same rationale upon which the proposed Welsh amendments are based).
If this rationale is accepted, then further tissues such as the anus, rectum, breasts (including skin from the breasts) and nipples should also be excluded from deemed consent. This is because they may be viewed as dual- or multi-purpose in that they both serve other biological functions and may be seen as sexual and reproductive tissues in much the same way as the perineum and prostate are (proposed additions to the list at Regulation 2(3) of the 2015 Regulations). These tissues may similarly be viewed as sensitive in nature. Given that ‘many [respondents] expressed concern about the transplantation of reproductive organs and tissues’ in the English consultation, including some but not all sexual and reproductive tissues seems inconsistent and unjustified. Even though many of these transplants are not yet surgically feasible, making the list of exclusions as comprehensive and as consistent as possible is desirable, as is ‘future proofing’ it to cover all reasonably foreseeable transplant types.
While we broadly agree with the additions, exclusions should not be based on novelty or ‘contentiousness’ alone. A broader range of considerations should be taken into account, such as:
- How willing would people be to donate if the donation-type in question was explained properly to them (even if it is not one that they have presently heard of?)
- Is the transplant for which the organ/tissue will be used lifesaving or quality-of-life enhancing?
Finally, rather than merely listing types of organ or tissue, it may be more appropriate (instead or as well) to incorporate a list of purposes for which transplanted materials may be used without explicit consent. This is because, for certain tissue types, potential donors may have very different views of donation depending on the use to which the tissue is put. For example, skin could be used as a dressing to facilitate wound healing but also for elective cosmetic surgery, and it is reasonable to suppose that some potential donors would be uncomfortable with the latter while maintaining a positive attitude to the former.
Question 3: Do you agree that ‘eye’ should remain in regulation 2(4), so that were the eye(s) ever able to be transplanted as part of a face transplant, express consent for the transplant of the eye(s) would always be required?
Yes
If no, please state why
Both the eyes and the face are often considered to be distinguishing features, closely tied to personal identity, and are imbued with emotional significance and spiritual meaning by many (as in the phrase ‘the eyes are the window to the soul’). There are reasons to suppose therefore that, for some people, concerns regarding donation will increase as more ‘facial’ tissue is donated and the recipient begins more closely to resemble the donor. In order to give due weight to those concerns and to maintain public confidence in the organ donation system, express consent for the transplant of eyes should be required.
Question 4: We would like to know your views on the effects that the changes we want to make to the 2015 regulations would have on the Welsh language, specifically on opportunities for people to use Welsh and on treating the Welsh language no less favourably than English. What effects do you think there would be? How could positive effects be increased, or negative effects be mitigated?
N/A
Question 5: Please also explain how you believe the proposed changes could be formulated or changed so as to have positive effects or increased positive effects on opportunities for people to use the Welsh language and on treating the Welsh language no less favourably than the English language, and no adverse effects on opportunities for people to use the Welsh language and on treating the Welsh language no less favourably than the English language.
N/A
Question 6 – We have asked a number of specific questions. If there are any issues related to the proposals raised in this consultation which we have not specifically addressed, please use this space to tell us about them.
Given the small number of responses submitted to the first Welsh consultation on organ and tissue exclusions, this second consultation on additions to the regulations would have been a valuable opportunity for the Welsh government to ascertain citizens’ views about all transplant exclusions. This is particularly important given the policy goal of respecting the wishes of prospective organ donors. The limited scope of this consultation thus represents a missed opportunity to gather evidence in support of both the new proposals and existing policy.
The consultation is due to run for a period of nine weeks, less than the usual recommended minimum of 12 weeks, with no explanation provided of the shorter timescale. This is particularly problematic in light of the COVID-19 pandemic (during which time the consultation was launched), which may mean that fewer people have had the chance to consider the relevant issues and to participate.
Finally, we suggest that the Organ Donor Register website should be updated to allow members of the public to record their donation preferences regarding excluded organs and tissues as well as routine transplants. This is particularly important given that proposed lists of exclusions may contain more than thirty specified transplants (depending on how organs and tissues are defined and categorised) and it is unlikely that family members will have discussed all the relevant exclusions with the deceased during their lifetime. This would be a better way to obtain consent for novel or contentious transplants, ensuring both respect for individual autonomy and that the decision is not left to family members who may find it difficult to determine donors’ preferences regarding novel/rare organs and tissues.
END
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